Coordinator, Quality Assurance (Licensing & Complaints)

Sun Pharmaceutical Industries Ltd•Brampton, ON

4d•CA$56,500 - CA$71,000•Onsite

About The Position

Sun Pharma is a leading global pharmaceutical company committed to providing high-quality medicines. The Coordinator, QA (Licensing and Complaints) is responsible for ensuring ongoing compliance with Good Manufacturing Practices (GMP) and regulatory and company requirements. This role manages and coordinates all activities associated with Site Licensing, including DEL and NHP licenses, and also supports the handling of product quality complaints and recall management.

Requirements

Bachelor's Degree in Science, or related discipline
3-5 Years' experience in a Quality Assurance, Quality Control or Manufacturing experience role within the pharmaceutical Industry preferably in handling investigations
Good working knowledge of pharmaceutical Quality Systems
Experience in coordinating team activities
Experience in dealing directly with Regulatory Agency officials (Health Canada and FDA)
Sound knowledge and application of Health Canada and FDA regulations
Strong focus on flexibility, ability to multi-task, attention to detail, excellent organizational skills, good follow-up, excellent communication and writing skills

Nice To Haves

Experience in Quality electronic systems such as Trackwise, Learning Management System (LMS) and SAP is an asset

Responsibilities

Support updates to Drug Establishment Licence (DEL), Natural Health Product (NHP) licences, and Table A.
Support the collection and maintenance of GMP evidence for Foreign Buildings.
Assist in the management of product quality complaints, including logging complaints, gathering relevant information, and issuing final reports.
Review and assess complaints and potentially defective products according to Sun Pharma Canada Inc. procedures and quality risk management principles.
Follow up with customers to obtain complaint samples or additional information required for investigations.
Notify Site Leadership Team of complaints that may require a field alert or recall assessment.
Support investigations by documenting findings, identifying root causes and implementing Corrective and Preventive Actions (CAPA's).
Assist in recall management activities in accordance with regulatory requirements.
Coordinate with cross-functional teams and Subject Matter Experts (SMEs).
Support trending of complaint data and preparation of metrics.
Author, review and maintain Standard Operating Procedures (SOPs).
Initiate, and follow through with actions required to close Change Controls.
Participate in internal, customer and regulatory audits.
Support the Product Inquiry Process.
Perform other duties as assigned.
Report any adverse event received from customers for company products to the pharmacovigilance department / Drug Safety on the same day or within 1 business day.